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WARNING LETTER

RE: CMS # 643745

Dear Dr. Pop and Mr. Rizun:

This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.coatedsilver.com in October 2022 and has determined that you take orders there for your Coated Silver product. Based on our review, the claims on your website establish that your Coated Silver product is a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease. Based on our review, this product is an unapproved new drug sold in violation of section 505(a) of the Act, 21 U.S.C. § 355(a). Furthermore, this product is a misbranded drug under section 502 of the Act, 21 U.S.C. § 352. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

The Department of Health and Human Services (HHS) has determined that a public health emergency exists nationwide involving mpox.^1,2 Therefore, FDA is taking measures to protect customers from products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure mpox. As described below, you sell a product intended to mitigate, prevent, treat, diagnose, or cure mpox in people. We request that you cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of mpox.

Examples of some of the website claims that provide evidence that your product is intended for use as a drug include the following:

On your April 12, 2021, blog post entitled, “Coated Colloidal Silver vs. Antibiotics,” www.coatedsilver.com/coated-colloidal-silver-vs-antibiotics/:
• “Does colloidal silver have an antibacterial effect?
Colloidal silver [an ingredient in your Coated Silver product] has antimicrobial properties. Also known as nanosilver, it has been shown to have negative effects on harmful microorganisms. Colloidal silver can kill bacteria, but also viruses and some strains of fungi. [5] Colloidal Silver is effective against viruses, bacteria, and even fungi. Scientists are also examining the potential of AgNPs [silver nanoparticles] to tackle deadly viruses. Among those being studied are isolated viruses of Tacaribe [6], Monkeypox [7] … 7. Rogers JV, Parkinson CV, Choi YW, Speshock JL, Hussain SM. A Preliminary Assessment of Silver Nanoparticle Inhibition of Monkeypox Virus Plaque Formation. Nanoscale Res Lett. 2008;3(4):129-133. Published 2008 Apr 9. doi:10.1007/s11671-008-9128-2 Access Date: 16 Apr 2021”

On your March 15, 2021, blog post entitled, “Does Colloidal Silver Have An Antibacterial Effect?”, www.coatedsilver.com/does-colloidal-silver-have-an-antibacterial-effect/:
• “Colloidal Silver Inhibits Bacterial Growth
Does colloidal silver [an ingredient in your Coated Silver product] have antibacterial properties? There is enough evidence to show that it does. Silver can kill bacteria and stop them from spreading.”

From your April 1, 2021, blog post entitled, “Coated Silver – Ultimate Immune Support”, www.coatedsilver.com/coated-silver-ultimate-immune-defense/:

• “The bacteria-fighting action of silver has been harnessed before penicillin was discovered in 1928. Physicians and medical practitioners used to prescribe silver as a cure for almost all kinds of illness.”
• “There is evidence showing that colloidal silver [an ingredient in your Coated Silver product] kills viruses. That includes HSV-1 and HIV-1.”

From your December 6, 2021, blog entitled, “What is drinking colloidal silver?”, www.coatedsilver.com/what-is-drinking-colloidal-silver/:

• “Silver nanoparticles have a strong Antibacterial Effect. These are used to decrease the risk of post-transplantation surgical infections. Transplanted devices are lined with silver on the surface to prevent the formation of biofilm which is a common cause of surgical site infection. Another widely accepted medical use of nanosilver particles is its topical use on wounds and burns.”
• “What is colloidal silver [an ingredient in your Coated Silver product] used to treat? Although a number of research studies show the promising use of colloidal silver for bacterial, viral, and fungal infections, more proof is needed to establish safety and effectiveness. Some studies even showed the coated silver Mechanism of Action improves the management of a growing number of chronic diseases. To date, the FDA has not issued any approved treatment use for colloidal silver.”

From your December 6, 2021, blog entitled, “How you can use colloidal silver?”, www.coatedsilver.com/how-you-can-use-colloidal-silver/:

• “Silver as an Antibacterial”
• “Silver as an Antiviral”
• “Silver for Faster Wound Healing”

Your Coated Silver product is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a “new drug” under section 201(p) of the Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act, 21 U.S.C. 355(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your Coated Silver product is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, your Coated Silver product fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. 331(a)].

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address these matters. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your written reply should be directed to Sara Dent Acosta, Compliance Officer, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835 or via email at [email protected]. If you have any questions, you may also email at [email protected].

Sincerely,
/S/

Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety and Applied Nutrition

_____________________

1 Secretary of Health and Human Services, Renewal of Determination that a Public Health Emergency Exists (issued Nov. 2, 2022), available at https://aspr.hhs.gov/legal/PHE/Pages/mpx-renewal-2Nov2022.aspx.

2 HHS has adopted the World Health Organization’s renaming of monkey pox to “mpox” to reduce stigma. Department of Health and Human Services, Biden Harris Administration Supports the World Health Organization Renaming of Monkeypox to mpox (issued Nov. 28, 2022), available at https://www.hhs.gov/about/news/2022/11/28/biden-harris-administration-supports-the-world-health-organization-renaming-of-monkeypox-to-mpox.html.